Quality SpecialistIndustry : Medical Device Role Summary: The Quality Specialist is a member of the Quality department and plays a key role in ensuring that the Quality System functions are maintained in compliance with documented procedures and applicable regulatory standards. The Quality Engineer supports design transfer activities to ensure ongoing compliance and continuous improvement. The position reports to the Quality Manager.
Role Responsibilities and Duties: Provide compliance oversight and guidance for design transfer activities, as assigned.Maintain awareness of applicable quality standards that regulate our industry. Maintain vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.Support and lead the review and approval of related design records.Support and/or lead the development and update of associated Risk Management files.Ensure compliant documentation, carrying out tasks related to the area of responsibility with management oversight.Support and/or lead product and process improvement activities from a quality perspective, ensuring supporting information/rationale for change including reasons and justifications is acceptable.Contribute to defining and timely achievement of overall design transfer project goals related to design control from transfer through product launch as assigned.Support and lead the development and implementation compliant solutions to problems/issues arising during design transfer/control activities, ensuring appropriate documentation of the event and subsequent resolution from a CAPA perspective.Provide guidance on IVDR related requirements.Involved in Complaint activities which support and guide in discharging regulatory obligations to conduct Complaint Handling, Vigilance Reporting, and Post Market Surveillance activities.Role Requirements: Excellent interpersonal, written and verbal communication skills, including the ability to convey appropriate information with clarity and effectiveness.Pro-active attitude, excellent organization skills, and the ability to manage multiple projects while delivering results on time.Proficient with MS Word, Excel, PowerPoint, and management of spreadsheets.Competent working knowledge of recognized Quality Management Systems and Global Medical Device regulations (e.g., ISO9001/ ISO13485/ ISO14971/ cGMP / CE/ FDA/ PAL/IVDR/MDSAP).Experience with IVDR requirements an advantage.Role Education & Experience: Third-level qualification in Science/ Engineering.Minimum 5 years of experience in the medical device industry with a minimum of 3 years of progressively responsible positions.In Vitro Diagnostics experience would be an advantage.Design Transfer experience would be an advantage.Location: Galway
Duration: 12-month fixed-term contract. The role would be hybrid, typically 3 days a week onsite and 2 days remote
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